EFUCERA PX

GUDID D080SSEPXXX36XLXC20

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device IDD080SSEPXXX36XLXC20
NIH Device Record Key0e3490fc-fde9-460c-a2ae-84eca2a96f13
Commercial Distribution StatusIn Commercial Distribution
Brand NameEFUCERA PX
Version Model Number8*1SET,36,L,C2
Company DUNS693430001
Company NameYAMAHACHI DENTAL MFG.,CO.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582276026831 [Secondary]
HIBCCD080SSEPXXX36XLXC20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, Plastic, Teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-26
Device Publish Date2018-01-27

On-Brand Devices [EFUCERA PX]

0458227602701236L, W0.5
0458227602700536U, W0.5
0458227602698536L, D4
0458227602697836U, D4
0458227602695436L, D3
0458227602694736U, D3
0458227602692336L, D2
0458227602691636U, D2
0458227602689336L, C4
0458227602688636U, C4
0458227602686236L, C3
0458227602685536U, C3
0458227602683136L, C2
0458227602682436U, C2
0458227602680036L, C1
0458227602679436U, C1
0458227602677036L, B4
0458227602676336U, B4
0458227602674936L, B3
0458227602673236U, B3
0458227602671836L, B2
0458227602670136U, B2
0458227602668836L, B1
0458227602667136U, B1
0458227602665736L, A4
0458227602664036U, A4
0458227602662636L, A3.5
0458227602661936U, A3.5
0458227602659636L, A3
0458227602658936U, A3
0458227602656536L, A2
0458227602655836U, A2
0458227602653436L, A1
0458227602652736U, A1
0458227602650334L, W0.5
0458227602649734U, W0.5
0458227602648034L, D4
0458227602647334U, D4
0458227602645934L, D3
0458227602644234U, D3
0458227602642834L, D2
0458227602641134U, D2
0458227602639834L, C4
0458227602638134U, C4
0458227602636734L, C3
0458227602635034U, C3
0458227602633634L, C2
0458227602632934U, C2
0458227602630534L, C1
0458227602629934U, C1

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